(121 days)
The intended use of this device (power/manual wheelchair) is the same as the predicate device, the Commuter (K934232). The intended use for the power/manual wheelchair is to provide mobility to physically impaired individuals. These chairs will allow the user to have a battery powered wheelchair or they can disengage the drive mechanism and have a manual wheelchair.
The specific medical conditions for which the device is indicated are listed as, but not limited to:
Spinal chord injury Stoke/CVA Post Polio Syndrome Spina Bifada Amputee Multiple Sclerosis Arthrogriposis Muscular Dystrophy Lower and upper extremity paralysis
The TiPower RimPower and PowerDrive X and SX are folding power/manual titanium wheelchairs.
The provided text describes the 510(k) summary for the TiPower RimPower and PowerDrive X & SX folding power/manual wheelchairs. This document focuses on demonstrating substantial equivalence to a predicate device (Commuter, K934232) and ensuring compliance with relevant standards, rather than detailing a clinical study with a device performance vs. acceptance criteria table, sample sizes, expert ground truth, or MRMC studies for AI devices.
Therefore, many of the requested elements for an AI device study are not applicable or cannot be extracted from this document, as it pertains to a physical medical device (wheelchair) and its compliance with established performance standards.
Here's a breakdown of what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets ISO 7176 Parts 1, 3, 5, 7, and 8 Standards | Meets these standards |
| Meets ANSI/RESNA WC/Vol. 2-1998 Section 21 | Meets this standard |
| Meets EN 12184:1999 | Meets this standard |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing involved compliance with engineering standards, not clinical data sets with "test sets" in the context of AI or imaging devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to this type of device and testing. Ground truth in this context refers to compliance with established engineering and safety standards, not expert medical diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to this type of device and testing. Adjudication methods are typically used in clinical trials or AI model evaluation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable as this is not an AI device or a diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as this is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is adherence to recognized international and national standards for wheelchairs (ISO 7176, ANSI/RESNA WC, EN 12184). These standards define objective performance and safety requirements.
8. The sample size for the training set
This information is not applicable as this is not an AI device with a "training set."
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI device with a "training set."
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JUN 2 0 2002
Image /page/0/Picture/1 description: The image is a logo with a black background. The letters 'Ti' are stacked vertically in white, with a white circle above the 'i'. Below the letters, the word 'SPORT' is written in smaller white letters. The logo appears to be for a sports-related brand or organization.
K020534
1052
THE TITANIUM WHEELCHAIR COMPANY
510(k) SUMMARY
Date: February 15, 2002
Present by:
Ms. Sandra Gladstone TiSport 1426 East Third Avenue Kennewick, WA 99337 509-586-6117 ext. 260 509-586-2413 fax
Trade / Proprietary Name: TiPower RimPower X and SX and TiPower PowerDrive X and SX
Common Name: Folding power/manual wheelchair
Classification Name: Powered Wheelchair (per 21 CFR section 890.3850)
Classification: Class II
Panel: Physical Medicine Device Prosthetic Devices Subpart D
Product Code: 890.3860 (Powered Wheelchair)
Legally Marketed Device Claiming Equivalence To: Commuter (K934232)
Description of Device: The TiPower RimPower and PowerDrive X and SX are folding power/manual titanium wheelchairs.
Intended Use of the Device: The intended use of this device is the same as the predicate device, the Commuter, manufactured by Fortress Lite-Style Wheelchairs, Inc. It is intended to provide mobility to physically impaired individuals while providing them with a power or manual propulsion method.
Target Population: The specific medical conditions for which the device is indicated are listed as, but not limited to:
Spinal chord injury Stoke/CVA Post Polio Syndrome Spina Bifada Amputee Multiple Sclerosis Arthrogriposis Muscular Dystrophy Lower and upper extremity paralysis
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K020539
20r2
Testing Results: Meets the requirements of the ISO 7176 Parts 1, 3, 5, 7,and 8 Standards (other parts not applicable) and ANSI/RESNA WC/Vol. 2-1998 Section 21 and EN 12184:1999.
Device Comparison: There are no significant functionality differences between the submitted device and the predicate device. However, the differences between the Commuter folding power/manual wheelchair and the TiPower RimPower and PowerDrive X and SX folding power/manual wheelchair are the materials used in the manufacturing of the frame and the power packs are made from a different company. The Commuter frame material is aluminum where the TiPower chair frames are made of titanium and the cross tubes are made from aluminum. TiSport believes that manufacturing the frames out of titanium vs. aluminum is a benefit not only from a safety perspective but clinically as well because of titanium's proven superior strength-to-weight ratio and its natural ability to absorb vibration. The power unit on the TiPower chairs performs the same function as the Commuter's power unit but we believe it is better because the battery is significantly smaller and lighter and the motor is in the wheel hub verses being mounted to the frame. The chair requires less human propulsion to move the chair and the power unit is more energy efficient. The rear wheels can be changed easily to lighter weight manual rear wheels. The TiPower offers a wider range of customization allowing for a better opportunity to properly "fit" the end user in a clinical setting as well as ensuring better safety and access to the chairs options and accessories.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 0 2002
Ms. Sandra Gladstone Vice President Operations TiSport 1426 East Third Avenue Kennewick, WA 99337
Re: K020539
Trade Name: TiPower RimPower and PowerDrive X & SX Regulatory Number: 890.3860 Regulatory Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: April 12, 2002 Received: April 15, 2002
Dear Ms. Gladstone
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Sandra Gladstone
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Sincerely yours,
Mark A. Milliken
Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ver/3-4/24/06
Applicant: TiSport
501(k) Number (if known): _
Devise Name: TiPower RimPower and PowerDrive X & SX
Indication for Use:
The intended use of this device (power/manual wheelchair) is the same as the predicate device, the Commuter (K934232). The intended use for the power/manual wheelchair is to provide mobility to physically impaired individuals. These chairs will allow the user to have a battery powered wheelchair or they can disengage the drive mechanism and have a manual wheelchair.
The specific medical conditions for which the device is indicated are listed as, but not limited to:
Spinal chord injury Stoke/CVA Post Polio Syndrome Spina Bifada Amputee Multiple Sclerosis Arthrogriposis Muscular Dystrophy Lower and upper extremity paralysis
DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Mellman
Division Sign-Division of General, Restorative and Neurologica
510(k) Number K020
(Per 21 CFR 801.109) Optional Format 1-2-96
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).